AccessGUDID - DEVICE: PALIUM COAXIAL (08058341215203)

GUDID

Device Identifier (DI) Information

Brand Name: PALIUM COAXIAL
Version or Model: MGC1210
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MGC1210
Company Name: M.D.L. S.R.L.

Primary DI Number: 08058341215203
Issuing Agency: GS1
Commercial Distribution End Date: April 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 447228586 *Terms of Use

Device Description: GUILLOTINE NEEDLE 12Gx 100 mm FOR SOFT TISSUE FOR PALIUM AND MAGNUM BARD TM WITH COXIAL 11G X 74MM

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45018	Needle guide, single-use	A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MJG	Device, Percutaneous, Biopsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4edbd14c-0b01-4e5d-90ff-5b563e072eb9
Public Version Date: February 16, 2024
Public Version Number: 7
DI Record Publish Date: June 07, 2018